Active not recruitingOBSERVATIONAL

Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia

This research is looking into a serious blood infection caused by bacteria called Staphylococcus aureus, which can be life-threatening. Even with current antibiotic treatments, it's a difficult infection to overcome. The study is re-analysing information from two previous clinical trials that explored adding an antibiotic called fosfomycin to standard treatment. While those trials didn't show big overall differences, they hinted that fosfomycin might help prevent the infection from lasting a long time in the blood. By combining and re-examining all this past data, researchers hope to figure out if there are specific groups of patients who would benefit most from this additional treatment. The goal is to improve how we treat this infection and help more patients recover fully.

At a glance

Status

Active not recruiting

Sponsor

Hospital Universitari de Bellvitge

Enrolment target

369

Start

01 Nov 2024

Estimated completion

31 Jan 2025

Staphylococcus Aureus Bacteremia

What is this study about?

This research focuses on a serious health problem called Staphylococcus aureus bacteraemia. This simply means you have a type of bacteria, called Staphylococcus aureus (often shortened to "Staph"), in your bloodstream. It can be a very dangerous and even life-threatening infection, despite doctors using standard antibiotics to treat it.

Doctors are always looking for better ways to treat this infection. This study is taking a closer look at whether adding an extra antibiotic, called fosfomycin, to the usual treatment could help. While two earlier studies didn't show a clear overall benefit from adding fosfomycin, they did suggest that it might help clear the infection from the blood more quickly in some patients. This new research is combining the information from those previous studies to see if they can find out precisely which patients might benefit the most.

The main aim is to understand the role of fosfomycin better. By carefully analysing all the past data, researchers hope to identify specific groups of patients – for example, based on their age or the type of Staph infection they have – who might respond particularly well to this combination treatment. This could lead to more effective and personalised treatment plans for people with this serious blood infection in the future.

Key takeaways

This study is analysing existing data on a serious blood infection.
It aims to see if an antibiotic called fosfomycin improves outcomes for some patients.
Researchers are looking for specific patient groups who might benefit most.
The goal is to improve future treatment of Staphylococcus aureus bacteraemia.
This is a review of past studies, not a new trial with new patients.

Who may be eligible?

This study is not actively recruiting new patients. Instead, it's analysing information that was already collected from people who took part in two previous studies called BACSARM and SAFO. So, you would have already been involved if you were part of those earlier trials.

When those original studies were recruiting, there were certain rules about who could take part. Generally, adults aged 18 and over with a Staphylococcus aureus blood infection were considered. However, people were not able to join if they had other serious health issues like multiple types of bacteria in their blood, had less than 24 hours to live, severe liver problems, or a specific heart valve infection. People with known allergies to the study drugs, pregnant women, or those already in another clinical trial were also excluded.

Each of the original studies also had a few additional specific rules. For instance, one study excluded people with particular lung infections or who were taking other antibiotics that would interfere with the study. The other study excluded people with a rare muscle condition called myasthenia gravis or a recent SARS-CoV2 infection. These rules were in place to make sure the studies were safe and the results were clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Were you an adult (18 years or older) when you were in the original study?
Did you have a Staphylococcus aureus blood infection?
Were you part of the BACSARM or SAFO clinical trials?
Did you not have certain severe existing health conditions at that time?

Answer every question to see your result.

What does participation involve?

Since this study is looking back at information from previous trials, there is no active participation required from patients. You won't need to visit a clinic, undergo new tests, take any medication, or have any follow-up appointments related to this specific research. Your involvement would have concluded when your participation in one of the original BACSARM or SAFO trials ended.

Potential risks and benefits

Since this is an analysis of existing data and not a new trial with patients, there are no direct new benefits or risks to individual patients. The potential benefit is to future patients, as the findings from this study could help doctors better understand which Staphylococcus aureus blood infection patients might benefit most from fosfomycin, potentially leading to improved treatment strategies. There is no right to withdraw from this data analysis, as it uses anonymised or de-identified data from people who already gave consent for their information to be used in research in the original trials. However, anyone wanting to revisit their consent from the original trials should contact the original study teams.

Locations (6)

The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity
Verified postcode
Melbourne, Australia
Institute of Health Policy, Management and Evaluation, University of Toronto
Verified postcode
Toronto, Canada
Hospital Universitari de Bellvitge
Verified postcode
L'Hospitalet de Llobregat, Spain
Germans Trias i Pujol Research Institute and Hospital (IGTP)
Verified postcode
Badalona, Spain
Hospital Clinic de Barcelona
Verified postcode
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Verified postcode
Barcelona, Spain

Common questions

What is Staphylococcus aureus bacteraemia?

It's a serious medical condition where a type of bacteria called Staphylococcus aureus gets into your bloodstream. It can cause severe illness.

What is fosfomycin?

Fosfomycin is an antibiotic, a type of medicine used to treat bacterial infections.

Is this a new clinical trial?

No, this study is reviewing information from two previous clinical trials. No new patients are being recruited or treated in this particular research.

Why are they re-examining old data?

To see if they can find patterns or specific patient groups that might benefit from fosfomycin, which wasn't fully clear from the individual studies on their own.

Will this research change current treatments?

The hope is that the findings could help doctors make more informed decisions about treating this infection in the future, potentially leading to better outcomes for patients.